Analysing the quality and authenticity of ACT drugs
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[Project summary in Français / Português]
Scientific title: Development of standardized methods for efficient representative sampling of drugs for laboratory analysis to obtain robust estimates of the frequency of counterfeit, substandard and degraded artemisinin containing drugs in countries.
Latest on this research
We purchased over 10,000 artemisinin containing combination antimalarials (ACCAs) in total from 6 countries - Cambodia, Ghana (Kintampo), Tanzania, Nigeria (Enugu and Ilorin), Rwanda and Equatorial Guinea (Bioko Island) following varying sample collection approaches (convenience, mystery client and overt) to provide effective surveillance of ACCAs available in a given geographical region.
Qualitative (mass spectrometry) and quantitative (high performance liquid chromatography or HPLC) content analyses to measure the amount of stated active pharmaceutical ingredients (SAPIs) were carried out in 3 independent laboratories. Results were expressed as percentage of SAPIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Compounds instead of the SAPIs were identified in the falsified samples.
Of the 10,322 samples (142 brands) substandard drugs were found in all 6 countries, while falsified formulations that did not contained the stated APIs were only found in 2 of the 6 countries.
Randomised sampling identified fewer falsified ACCAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling approach used if representative information on drug quality is to be obtained. The results were disseminated to the country-specific ministries of health, as well as relevant manufacturers.
Scroll down for all the resources related to this study, including peer reviewed publications , press releases, a policy brief and the report of a drug quality meeting entitled "Fake antimalarials: start with the facts" hosted by the ACT Consortium on 28th May 2015 in Geneva, Switzerland.
What did we know before this research?
The World Health Organization recommends artemisinin-based combination therapy (ACT) as the first-line treatment for malaria. This consists of combining two drugs: artemisinin (which derives from the artemisia plant) and a partner drug (one of existing antimalarials). If taken alone rather than combined, they are considered monotherapies and are less effective.
Governments have purchased millions of these expensive drugs over the past decade. However, some evidence from South East Asia in 2002 suggests that there are cases of fake antimalarials. This is often reported in the news and spreads alarm.
The quality of drugs is extremely important, as poor quality drugs (which contain the wrong amounts of artemisinin) may contribute to the development of drug resistance and patients who are not treated properly are at risk of dying.
What does this study add?
With this project we aim to understand whether there are reasons to be concerned about the quality and authenticity of ACT drugs in Africa.
The study assesses the quality of drugs deriving from artemisinin in six countries. This is done through surveilling the frequency of poor quality malaria drugs as well as laboratory and field based studies.
Our aim is to maximise the efforts of malaria control globally by analysing samples from several countries and working closely with national health ministries.
The research team has used and assessed methodologies to understand how to best collect drug samples. This will enable an accurate assessment of the prevalence of poor quality drugs in a country.
The research team
Principal Investigator
- Dr Harparkash Kaur, London School of Hygiene & Tropical Medicine
Email: harparkash.kaur@lshtm.ac.uk
Other Investigators
- Dr Facundo M. Fernandez, Georgia Institute of Technology, Atlanta, USA. (Drug Forensics)
- Dr Paul Newton, Centre for Clinical, Tropical Medicine, Churchill Hospital, Oxford University, Oxford UK and LSHTM, UK.
- Dr Michael D. Green, Centre for Disease Control and Prevention, Atlanta, USA
- Dr Sian Clarke, London School of Hygiene & Tropical Medicine, UK
Country-specific Investigators
- Dr Obinna Onwujekwe, College of Medicine, University of Nigeria
- Dr Catherine Goodman, London School of Hygiene & Tropical Medicine, UK
- Dr Shunmay Yeung, London School of Hygiene & Tropical Medicine, UK
- Dr. Seth Owusu-Agyei, Kintampo Health Research Centre, Kintampo
- Matthew Chico, London School of Hygiene & Tropical Medicine, UK
Related Publications
High throughput quantitation of artesunate and its degradation products by flow injection gradient ratio standard addition mass spectrometry (FI-GRSA-MS)†
Dana M. Hostetler, Prabha Dwivedi, Michael D. Green and Facundo M. Fernandez | Published
Analytical Methods
Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa
Gaurvika M L Nayyar, Joel G Breman, Paul N Newton, James Herrington | Published
Lancet
Poor quality vital anti-malarials in Africa - an urgent neglected public health priority
Paul N Newton, Michael D Green, Dallas C Mildenhall, Aline Planon, Henry Nettey, Leonard Nyadong, Dana M Hostetler, Isabel Swamidoss, Glenn A Harris, Kristen Powell, Ans E Timmermans, Abdinasir A Amin, Stephen K Opuni, Serge Barbereau, Claude Faurant, Ra | Published
Malaria Journal
The primacy of public health Considerations in defining poor quality medicines
Paul N. Newton, Abdinasir A. Amin, Chris Bird, Phillip Passmore, Graham Dukes, Go ran Tomson, Bright Simons, Roger Bate, Philippe J. Guerin, Nicholas J. White | Published
PLos Medicine
Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries
Facundo M. Fernandez, Dana Hostetlera, Kristen Powella, Harparkash Kaurb, Michael D. Greenc, Dallas C. Mildenhalld, and Paul N. Newton | Published
Analyst
Antimalarial drug quality: methods to detect suspect drugs
Harparkash Kaur, Michael D Green, Dana M Hostetler, Facundo M Fernndez & Paul N Newton | Published
Future Medicine
A tiered analytical approach for investigating poor quality emergency contraceptives
Mara Eugenia Monge, Prabha Dwivedi, Manshui Zhou, Michael Payne, Chris Harris, Blaine House, Yvonne Juggins, Peter Cizmarik, Paul N. Newton, Facundo M. Fernndez, David Jenkins | Published
PLOS ONE
Quality of artemisinin-containing antimalarials in Tanzania’s private sector— Results from a nationally representative outlet survey
ACT Consortium Drug Quality Project Team and the IMPACT2 Study Team | Published
American Journal of Tropical Medicine and Hygiene - Supplement on the Pandemic of Falsified Medicines
Quality of antimalarials at the epicenter of antimalarial drug resistance: Results from an overt and mystery client survey in Cambodia
Shunmay Yeung, Harriet L. S. Lawford, Patricia Tabernero, Chea Nguon, Albert van Wyk, Naiela Malik, Mikhael DeSousa, Ouk Rada, Mam Boravann, Prabha Dwivedi, Dana M. Hostetler, Isabel Swamidoss, Michael D. Green, Facundo M. Fernandez, Harparkash Kaur | Published
American Journal of Tropical Medicine and Hygiene - Supplement on the Pandemic of Falsified Medicines
Quality of artemisinin-based combination formulations for Malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
Harparkash Kaur, Elizabeth Louise Allan, Ibrahim Mamadu, Zoe Hall, Ogochukwu Ibe, Mohamed El Sherbiny, Albert van Wyk, Shunmay Yeung, Isabel Swamidoss, Michael D. Green, Prabha Dwivedi, Maria Julia Culzoni, Sin Clarke, Obinna Onwujekwe | Published
PLOS ONE
Fake anti-malarials: start with the facts
Harparkash Kaur, Siȃn Clarke, Mirza Lalani, Souly Phanouvong, Philippe Gurin, Andrew McLoughlin, Benjamin K. Wilson, Michael Deats, Aline Planon, Heidi Hopkins, Debora Miranda and David Schellenberg | Published
Malaria Journal
Degradation of Artemisinin-Based Combination Therapies Under Tropical Conditions
Zoe Hall, Elizabeth Louise Allan, Donelly Andrew van Schalkwyk, Albert van Wyk, and Harparkash Kaur | Published
The American Society of Tropical Medicine and Hygiene